BOSTON — Three former executives of Magellan Diagnostics, a medical device company headquartered in Billerica, have been sentenced in federal court in Boston for concealing a device malfunction that produced inaccurately low lead-test results for thousands of children and other patients, federal officials announced Monday.
According to a statement from the U.S. Attorney’s Office for the District of Massachusetts, Amy Winslow, 54, of Needham — Magellan’s former CEO — was sentenced by U.S. Senior District Court Judge Patti Saris on Oct. 27, 2025, to one year of home detention and ordered to pay a $10,000 fine. In March 2025, Winslow pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce.
Hossein Maleknia, 66, of Bonita Springs, Florida — the company’s former chief operating officer — was sentenced by the same judge on Oct. 30, 2025, to nine months of home detention and ordered to pay a $20,000 fine. In March 2025, Maleknia pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce.
Former Director of Quality Assurance and Regulatory Affairs Reba Daoust, 69, of Amesbury, was sentenced by Judge Saris on Nov. 21, 2025, to one year of probation, with the first six months to be served in home detention, and ordered to pay a $600 fine. In March 2025, Daoust pleaded guilty to one felony count of making false statements.
According to federal prosecutors, Magellan’s LeadCare II and LeadCare Ultra devices were used nationwide to detect lead levels in children and adults through both fingerstick and venous blood samples. LeadCare II, primarily used for fingerstick tests, accounted for more than half of all blood lead tests conducted in the United States between 2013 and 2017. LeadCare Ultra was primarily used to test venous samples.
Investigators say the devices could not accurately test venous blood samples, yet the three executives misled customers and the FDA about the malfunction, as well as the timing and severity of the problem. The government estimates that thousands of patients received falsely low lead test results as a result.
“These defendants knowingly misled the FDA about a device malfunction that caused thousands of children and adults to receive inaccurate blood lead test results,” U.S. Attorney Leah B. Foley said in a statement. “They understood the risks: that patients could receive falsely low readings, when their actual blood lead levels met or exceeded CDC intervention thresholds. They knew this failure could delay critical care, allow continued lead exposure and endanger the health of vulnerable families. Yet they chose to conceal the truth, prioritizing corporate profits, job security, and personal gain over patient safety. Regardless of the sentences imposed, their actions jeopardized the wellbeing of thousands. We will continue to uncover and prosecute those who violate the public’s trust and put public health at risk.
Federal officials said the FDA later ordered a recall of all LeadCare devices used on venous blood samples and issued a public warning advising they should no longer be used for that type of testing.
“According to court documents, as referenced by the Centers for Disease Control and Prevention, there is no safe level of lead in the blood,” the U.S. Attorney’s Office for the District of Massachusetts said in its statement. Adding, “Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead.
The case is being prosecuted by Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin of the Health Care Fraud Unit.
